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Interim Report 2019 wuxi apptec IR2019 Cover 12.9mm output.pdf 1 16/9/2019 下午4:56 無錫藥明康德新藥開發股份有限公司 無錫藥明康德新藥開發股份有限公司 WuXi AppTec Co., Ltd.* WuXi AppTec Co., Ltd.* （於中華人民共和國註冊成立的股份有限公司） (A joint stock company incorporated in the People’s Republic of China with limited liability) 股份代碼：2359 Stock Code : 2359 W uXi App C M Y T CM ec Co., Ltd. MY CY CMY K * INTERIM REPORT INTERIM REPORT INTERIM 中期報告 2019 REPORT 2019 中期報告 2019 CONTENTS CORPORATE INFORMATION 2 FINANCIAL HIGHLIGHTS 4 MANAGEMENT DISCUSSION AND ANALYSIS 5 STATUTORY DISCLOSURES 31 REPORT ON REVIEW OF CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 47 CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME 48 CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION 50 CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY 52 CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS 54 NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 56 DEFINITIONS 110 CORPORATE INFORMATION BOARD OF DIRECTORS REMUNERATION AND APPRAISAL Executive Directors COMMITTEE Dr. Ge Li (李革) Ms. Yan Liu (劉艷) (Chairperson) 婁賀統 (Chairman and Chief Executive Officer) Dr. Hetong Lou ( ) Mr. Edward Hu (胡正國) Dr. Ning Zhao (趙寧) (Co-Chief Executive Officer) Mr. Xiaozhong Liu (劉曉鐘) NOMINATION COMMITTEE 張朝暉 Mr. Zhaohui Zhang ( ) Dr. Jiangnan Cai (蔡江南) (Chairperson) 趙寧 Dr. Ning Zhao ( ) Ms. Yan Liu (劉艷) Dr. Ge Li (李革) Non-executive Directors Mr. Xiaomeng Tong (童小幪) AUDITOR Dr. Yibing Wu (吳亦兵) Deloitte Touche Tohmatsu Certified Public Accountants Independent Non-executive Directors 35/F, One Pacific Place Dr. Jiangnan Cai (蔡江南) 88 Queensway Ms. Yan Liu (劉艷) Hong Kong Mr. Dai Feng (馮岱) Dr. Hetong Lou (婁賀統) REGISTERED OFFICE IN THE PRC Mr. Xiaotong Zhang (張曉彤) Mashan No. 5 Bridge JOINT COMPANY SECRETARIES Binhu District Wuxi Mr. Chi Yao (姚馳) Jiangsu Province Ms. Yuen Wing Yan Winnie (袁頴欣) PRC AUTHORISED REPRESENTATIVES HEADQUARTERS AND PRINCIPAL Mr. Edward Hu (胡正國) PLACE OF BUSINESS IN THE PRC Mr. Chi Yao (姚馳) 288 Fute Zhong Road Waigaoqiao Free Trade Zone STRATEGY COMMITTEE Shanghai PRC Dr. Ge Li (李革) (Chairperson) Mr. Edward Hu (胡正國) Mr. Xiaomeng Tong (童小幪) PRINCIPAL PLACE OF BUSINESS Dr. Yibing Wu (吳亦兵) IN HONG KONG 蔡江南 Dr. Jiangnan Cai ( ) Level 54, Hopewell Centre 183 Queen’s Road East AUDIT COMMITTEE Hong Kong Dr. Hetong Lou (婁賀統) (Chairperson) Mr. Xiaotong Zhang (張曉彤) Ms. Yan Liu (劉艷) 2 WuXi AppTec Co., Ltd. Interim Report 2019 CORPORATE INFORMATION PRINCIPAL BANKERS COMPLIANCE ADVISER HSBC Bank (China) Company Limited Somerley Capital Limited (Shanghai Branch) 20th Floor 26th Floor, HSBC Building China Building Shanghai IFC 29 Queen‘s Road Central 8 Century Avenue Hong Kong Pudong District Shanghai HONG KONG LEGAL ADVISER PRC Wilson Sonsini Goodrich & Rosati Suite 1509, 15/F, Jardine House Shanghai Pudong Development Bank 1 Connaught Place, Central (Baoshan Branch) Hong Kong No. 1283 Mudanjiang Road Baoshan District Shanghai PRC LEGAL ADVISER PRC Fangda Partners 24/F, HKRI Centre Two Agricultural Bank of China Limited HKRI Taikoo Hui 288 (Caojing Branch) Shi Men Yi Road No. 118 Zhifu Road Shanghai Caojing Town PRC Jinshan District Shanghai A SHARE REGISTRAR AND PRC TRANSFER OFFICE IN THE PRC China Merchants Bank China Securities Depository & (Waigaoqiao Branch) Clearing Corporation Limited No. 333 Fute West 1st Road (CSDCC) Shanghai Branch Pudong District China Insurance Building Shanghai 166 East Lujiazui Road PRC Pudong District, Shanghai PRC JPMorgan Chase Bank (China) Company Limited 41st Floor, Park Place H SHARE REGISTRAR No. 1601 West Nanjing Road Tricor Investor Services Limited Jing’an District Level 54, Hopewell Centre Shanghai 183 Queen’s Road East PRC Hong Kong Citibank Citi Tower STOCK CODE No. 33 Hua Yuan Shi Qiao Road A Share: 603259 Lu Jia Zui Finance and Trade Zone H Share: 02359 Shanghai PRC COMPANY’S WEBSITE www.wuxiapptec.com.cn Interim Report 2019 WuXi AppTec Co., Ltd. 3 FINANCIAL HIGHLIGHTS Six months ended June 30, 2019 2018 RMB million RMB million Operating results Revenue 5,894.4 4,409.2 Gross profit 2,283.6 1,756.1 Operating profit 1,261.4 1,440.7 Net profit for the period 1,105.0 1,304.1 Net profit attributable to the owners of the Company 1,056.8 1,271.9 Adjusted non-IFRS net profit attributable to the owners of the Company 1,178.7 893.0 Profitability Gross profit margin 38.7% 39.8% Operating profit margin 21.4% 32.7% Net profit attributable to the owners of the Company margin 17.9% 28.8% Adjusted non-IFRS net profit attributable to the owners of the Company margin 20.0% 20.3% Earnings per share (RMB) — Basic 0.65 0.93 — Diluted 0.64 0.93 Adjusted non-IFRS earnings per share (RMB) — Basic 0.72 0.66 — Diluted 0.72 0.66 June 30, December 31, 2019 2018 RMB million RMB million Financial position Total assets 24,428.4 22,667.2 Equity attributable to the owners of the company 17,756.1 17,688.0 Total liabilities 6,299.3 4,502.0 Bank balances and cash 3,699.8 5,757.7 Gearing ratio 25.8% 19.9% 4 WuXi AppTec Co., Ltd. Interim Report 2019 MANAGEMENT DISCUSSION AND ANALYSIS BUSINESS REVIEW 1. The Board’s Discussion and Analysis on Operations of the Group for the Reporting Period A. Analysis on Principal Operations During the Reporting Period, we maintained strong growth momentum across all business segments. For the Reporting Period, we realized revenue of RMB5,894.4 million, representing a year-over-year (“YoY”) growth of 33.7%. During the Reporting Period, we realized net profit attributable to the owners of the Company of RMB1,056.8 million, representing a YoY decrease of 16.9%. Our adjusted non-IFRS net profit attributable to owners of the Company for the Reporting Period amounted to approximately RMB1,178.7 million, representing a YoY growth of 32.0%. Please refer to “B. Non-IFRS Measure” below for details. We continued to increase customer penetration, acquire new customers, especially global “long-tail” customers, and expand our services to China customers. During the Reporting Period, we acquired nearly 600 new customers and our active customer count reached more than 3,600. By leveraging the strengths of our integrated end-to-end R&D services platform, we were able to create further synergies across all our segments and continuously expand our scope of services through our “follow the project” and “follow the molecule” strategies. We continued to enhance our capacities and capabilities across all segments and facilities. During the Reporting Period, our newly built Qidong research and development center began operation, and will become an extension of our Shanghai headquarter in the future. Three of our Laboratory Testing Division’s facilities, namely drug safety testing, bioanalytical services and medical device testing, completed regulatory inspections by FDA, OECD, and CNAS, all with excellent results. Our cell and gene therapies CDMO/CMO facility in Wuxi city began operation, providing services to customers in China. New drug product manufacturing facility of our subsidiary, STA, in Shanghai passed its first GMP inspection by the European Medical Products Agency. In July 2019, STA’s ASU facility in Shanghai and API process R&D and manufacturing facility in Changzhou successfully passed two inspections by the FDA, with no Form 483 (i.e. a form used by the FDA to document and communicate concerns discovered during the inspections) issued. Revenue During the Reporting Period, we realized revenue of RMB5,894.4 million, representing a YoY growth of 33.7%. Our China-based laboratory services realized revenue of RMB2,988.9 million, representing a YoY growth of 23.7%, our CDMO/CMO services realized revenue of RMB1,717.7 million, representing a YoY growth of 42.0%, our U.S.-based laboratory services realized revenue of RMB709.8 million, representing a YoY growth of 30.0%, while our clinical research and other CRO services realized revenue of RMB472.1 million, representing a YoY growth of 104.2%. Interim Report 2019 WuXi AppTec Co., Ltd. 5 MANAGEMENT DISCUSSION AND ANALYSIS (1) China-based laboratory services During the Reporting Period, our China-based laboratory services realized revenue of RMB2,988.9 million, representing a YoY growth of 23.7%. We have one of the largest and most experienced small molecule chemical drug R&D teams globally, along with a comprehensive testing platform. We assisted our global customers in pushing forward R&D progress of innovative pharmaceutical products and we continued to enable our domestic customers with our market-leading expertise. In small molecule drug discovery, during the Reporting Period, we assisted global customers in developing many pre-clinical candidate molecules and applied for patents, with various research papers published. We have built a DNA-encoded library with approximately 90 billion compounds, enabling a growing number of customers globally to discover innovative small molecule drugs. In laboratory testing, our services include analytical chemistry, DMPK/ADME, toxicology and bioanalytical testing. In addition, we fully leverage the advantage of the platform and combine our technical experience, program management and regulatory expertise to facilitate submission of our customers’ IND package. During the Reporting Period, we provided WIND services to many global and domestic customers, and for the first time helped our customers obtain FDA clinical trial approval under eCTD format. In addition, we provided integrated drug discovery and R&D services to Chinese customers which span from early stage drug discovery to completion of IND filings with NMPA. These projects have success-based agreements that provide us with a milestone and/or royalty fee. During the Reporting Period, we assisted Chinese customers in making 10 IND filings with NMPA for new-chemical entities and assisted our customers in obtaining 11 CTAs from NMPA. As at June 30, 2019, we have in total assisted Chinese customers in submitting 65 new-chemical entities IND filings and obtained 45 CTAs from NMPA.
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